Dupilumab Added to Standard Topical Corticosteroid in Severe Atopic Dermatitis



Title: Long-term management of moderate-to-severe atopic dermatitis with dupilumab and concomitant topical corticosteroids (LIBERTY AD CHRONOS): a 1-year, randomised, double-blind, placebo-controlled, phase 3 trial

Blauvelt A. et al.


 

What You Need to Know:

When treating moderate to severe atopic dermatitis, addition of dupilumab to standard therapy of a topical corticosteroid improved signs and symptoms of the disease with acceptable safety.

Trial Design:

  • Double-blinded, placebo-controlled, phase 3 study (LIBERTY AD CHRONOS) evaluated the long-term safety and efficacy of dupilumab compared to placebo in adults with moderate-severe atopic dermatitis
  • 740 patients were randomized (3:1:3) to receive dupilumab 300mg subcutaneously once weekly (qw), dupilumab 300mg subcutaneously every 2 weeks (q2w), or placebo for 1 year
  • Concomitant medium-potency topical corticosteroids (CS) were administered to each group and utilized or discontinued depending on a patient's disease severity
  • Coprimary endpoints: from baseline, percent of patients attaining Investigator's Global Assessment (IGA) 0/1 and 2-point increase and 75% improvement in the Eczema Area and Severity Index (EASI-75) from baseline week 16

Key Outcomes:

  • 39% of dupilumab + CS qw patients (125/319) and 39% of dupilumab + CS q2w patients (41/106) attained coprimary endopoint of IGA 0/1 vs 12% of placebo + CS patients (39/315) (P<0.0001) at week 16
  • 64% of dupilumab + CS qw patients (204/319) and 69% of dupilumab + CS q2w patients (73/106) attained coprimary endopoint of EASI-75 vs 23% of placebo + CS patients (73/315) (P<0.0001) at week 16
  • Similar results seen at week 52
  • 83% of dupilumab + CS qw patients (261/319) and 88% of dupilumab + CS q2w patients (97/106) reported adverse events compared to 84% of placebo patients (266/315)
  • Rates of serious adverse events similar among all groups (3-5%)
  • No significant laboratory abnormalities were reported
  • Most commonly reported adverse events for dupilumab treated patients: injection-site reactions, conjunctivitis